Tagged with US

Pharma Legal Handbook All about preclinical and clinical trial requirements in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. Are clinical trials required to be conducted locally as a condition (stated or…

Pharma Legal Handbook An intro to the legal situation for regulatory, pricing and reimbursement in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for GBP 99.     1. What are the regulatory authorities with jurisdiction…

Brazil The latest news from Brazilian pharma, including an investigation into the country’s deal with Indian lab Bharat Biotech to purchase COVID-19 vaccines; the IP and regulatory challenges around personalised medicine in Brazil; and how domestic champion EMS surged in performance in 2020 thanks to COVID.   Brazil probes Health Ministry…

Japan Writing in the June edition of DIA’s Global Forum magazine, representatives of Japanese pharmaceutical companies with US operations outline how the COVID-19 pandemic affected their ongoing clinical studies.   The spread of COVID-19 and the resulting social activity restrictions have severely impacted drug development and threatened the continuity of clinical…

Mexico The latest news from Mexican pharma, including Bayer’s big bet on oncology and Novartis’ aggressive expansion strategy as well as updates on the country’s vaccination drive, including the upcoming rollout of the J&J jab, why the country’s doctors are being denied vaccines, and the progression of trials for the Sanofi…

USA Dan Leonard of the Association for Accessible Medicines (AAM) highlights five key takeaways from the organisation’s remote but dynamic annual conference, and how the US generics and biosimilars industry might evolve post-COVID.   AAM and our member companies have experienced a year like no other, and the lessons of the…

USA With the US FDA’s controversial recent decision to approve Biogen and Eisai’s aducanumab – the first approval for a new Alzheimer’s disease (AD) drug since 2003 – PharmaBoardroom has raided its archives to bring key industry stakeholders’ takes on the significance of this decision and what it might mean for…

Mexico There is no doubt that COVID-19 has impacted almost every aspect of our lives. Due to the ongoing health crisis, among other efforts, governments have implemented measures expecting to break high rates of infection while trying to adapt the regulatory landscape to respond to the new virus and continuing to…

USA Taking the example of music’s effect on Alzheimer’s disease patients, John G Singer makes the case for a more holistic approach to healthcare; focusing less on the transformative potential of individual drugs and more on value as a stream of benefits delivered through a living system.   Singer/songwriter Glen Campbell,…

Germany The latest news from German pharma, including a new US leadership team and more COVID-related investment at Merck KGaA; the CureVac vaccine’s role in fighting COVID-19 variants; and why the country is trailing its European neighbours in digital health.   Merck KGaA’s new CEO shakes up U.S. leadership to spark…

Switzerland Interpharma’s Dr René P. Buholzer highlights the key lessons that Switzerland’s innovative pharmaceutical industry has taken from the COVID-19 pandemic, the challenges inherent in the country’s two upcoming cost containment packages, and progress made on the circuitous journey towards a more standardised national health data ecosystem.   Switzerland wants to…

Turkey AmCham Turkey’s executive director, Asli Özelli, examines the impact of US companies on the Turkish economy with over USD 50 billion in investment, their help during the pandemic, the chamber’s efforts to develop local talent and take advantage of the country’s advanced healthcare infrastructure to promote medical tourism, and explains…